Cem-Ostetic Granules CemO-20G

GUDID 00858418003454

Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implanted, Cem-Ostetic resorbs and is later replaced by natural bone. Cem-Ostetic is a natural choice for sparing patients the trauma of autograft harvesting. It also provides a safe alternative to human or animal cadaver bone that completely eliminates the potential for disease transmission. Cem-Ostetic is an osteoconductive bone substitute shaped as granules that are intended to be used to fill voids and gaps that are not intrinsic to the stability of the bone structure. These gaps or voids may be located in the extremities, spine, pelvis, or cranium. The granules may be pressed into the void or into the surgical site by hand. The Cem-Ostetic granules provide void filling material that acts as a temporary support medium. The granules are not intended to provide structural support during the healing process. The implant is radio-opaque. Cem-Ostetic is biocompatible and resorbs in the body as bone ingrowth occurs.

BERKELEY ADVANCED BIOMATERIALS, LLC

Bone matrix implant, synthetic
Primary Device ID00858418003454
NIH Device Record Keyc62b33c1-16f9-47a2-a9d7-e67552c02c55
Commercial Distribution StatusIn Commercial Distribution
Brand NameCem-Ostetic Granules
Version Model NumberCemO-20G
Catalog NumberCemO-20G
Company DUNS081067703
Company NameBERKELEY ADVANCED BIOMATERIALS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858418003454 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-23
Device Publish Date2016-04-10

On-Brand Devices [Cem-Ostetic Granules]

00858418003829Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003461Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003454Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003447Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003430Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003423Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003416Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan
00858418003409Cem-Ostetic is a bio-engineered mixture of calcium-based inorganic compounds. After it is implan

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